Verification of Microbiology Tests - SWACM
Verification of Microbiology Tests - SWACM Verification of Microbiology Tests - SWACM
Modified Tests and LDTs—Number of Specimens to Test • Cumitech 31A: recommended number of specimens – ≥ 50 positive specimens – ≥ 100 negative specimens – Rationale: scientifically justified, and laboratories performing LDTs or modified tests have resources to perform larger studies – Number of samples may depend on extent of modification – This is a recommendation. Neither CLIA nor CAP specify number of specimens Source: Cumitech 31A 20
Verification Report • Summarize performance—did it meet your acceptance criteria (as defined in a verification protocol) • Attach raw data • Director (or designee) must sign the report, documenting that the test does indeed perform as per manufacturer’s specifications • Keep report for life of assay, plus 2 years 21
- Page 1 and 2: Verification of Microbiology Tests
- Page 3 and 4: Definitions • Modified test: FDA-
- Page 5 and 6: Verification Components • Accurac
- Page 7: Verification of Unmodified FDA- Cle
- Page 11 and 12: Verification of Unmodified FDA- Cle
- Page 13 and 14: Verification of AST • At least 30
- Page 15 and 16: Modified Tests and Laboratory- Deve
- Page 17 and 18: Modification Examples • Change in
- Page 19: Verification vs. Establishment of
- Page 23: Acknowledgments • Cumitech 31A co
<strong>Verification</strong> Report<br />
• Summarize performance—did it meet your<br />
acceptance criteria (as defined in a verification<br />
protocol)<br />
• Attach raw data<br />
• Director (or designee) must sign the report,<br />
documenting that the test does indeed<br />
perform as per manufacturer’s specifications<br />
• Keep report for life <strong>of</strong> assay, plus 2 years<br />
21
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